Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER MEDICAL CUB CADET; BED, PEDIATRIC OPEN HOSPITAL
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER MEDICAL CUB CADET; BED, PEDIATRIC OPEN HOSPITAL Back to Search Results
Model Number FL19H
Device Problem Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/22/2013
Event Type  malfunction  
Event Description
The nurse placed the patient in the crib and placed the side rails up in their locked position with the plastic top latched.The nurse responded to the patient and found him on the floor outside of the crib.The side rails were still in the upright locked position.The plastic cover was noted to be opened slightly.The opened space did not appear to be the mechanism that allowed the patient to exit the crib.Concern noted that the patient may have been able to reach and unhook the latches on the side rails with the access doors, possibly explaining his exit from the crib.Question if a device could be placed over the latches on the crib to prevent a child from inadvertently opening the latches.Question if a visual cue could be added to the crib to validate the locking mechanisms are engaged.Question if a color code of red and green could be added to signify a locked verses an unlocked state.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CUB CADET
Type of Device
BED, PEDIATRIC OPEN HOSPITAL
Manufacturer (Section D)
STRYKER MEDICAL
3800 east centre avenue
portage MI 49002 582
MDR Report Key3623884
MDR Text Key4208829
Report Number3623884
Device Sequence Number1
Product Code FMS
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Invalid Data
Device Model NumberFL19H
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/30/2014
Event Location Hospital
Date Report to Manufacturer02/12/2014
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/30/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age3 YR
Patient Weight14
-
-